Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.

Keratoconus Clinical Trial

Official title:

Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845714
• Other study ID #: EIT-KC-VSQOL3
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: January 14, 2017
• Start date: April 2009
• Est. completion date: October 2012

Study information

• Verified date: January 2017
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus

• present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.

Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:

• an increase of 1.00 diopter (D) or more in the steepest keratometry measurement

• an increase of 1.00 D or more in manifest cylinder

• an increase of 0.50 D or more in manifest refraction spherical equivalent.

Exclusion Criteria:

• glaucoma

• suspicion for glaucoma

• IOP-lowering medications

• central corneal thickness (CCT) less than 400µm

• K-readings more than 60D

• history of herpetic keratitis

• corneal scarring

• severe eye dryness

• pregnancy or nursing

• current corneal infection

• or underlying autoimmune disease KG members were further sub-divided into CxL and tCxL groups, according to their eligibility for treatment with CxL or CxL with tPRK. In order to be eligible for tCxL, group participants should, additionally, have CCT above 450µm.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Corneal Cross Linking

• Corneal Cross Linking combined with topoguided PRK

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

References & Publications (1)

Labiris G, Giarmoukakis A, Sideroudi H, Kozobolis V. Impact of keratoconus, cross-linking and cross-linking combined with topography-guided photorefractive keratectomy on self-reported quality of life: a 3-year update. Cornea. 2013 Sep;32(9):e186-8. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision Specific quality of Life (VS-QoL)		3 years